Office of Research & Regulatory Affairs (IRB)

The mission of Cook County Health’s Institutional Review Board (IRB) is to protect human participants involved in research conducted by or through Cook County Health and to ensure all research is conducted in accordance with ethical principles and all applicable regulations.

The IRB serves as the Board of Record for all Cook County Health affiliates.

The Office of Research & Regulatory Affairs provides: administrative support to the IRB; review process for all protocol applications; feedback to investigator; correspondence with investigators; educational programs and audits.

Federal Wide Assurance (FWA)

Cook County Health IRB has filed a Federal Wide Assurance (FWA) with the Department of Health and Human Services (DHHS), in which we promise to uphold federal regulations and ethical principles for human participants in research conducted by employees, agents and affiliates of Cook County Health.

FWA number: FWA00001802

IRB Registration Information Letter (IORG)

The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) require IRBs to register through a system maintained by DHHS.

IRB Organization (IORG) number: IORG0000119

Research Financial Conflict of Interest Policy – Updated July 2022

Guide for Investigators

The Guide for Investigators is an effort to describe expectations and provide some operational guidance for the ethical conduct of research done at all affiliates of Cook County Health. Our guide is currently under revision. As new sections are completed, they will be posted here.

Guide for Investigators – Under Revision

IRB Manager

IRB Manager, our web-based submission system, allows users to enter protocols and protocol related information such as: new submissions, progress reports, adverse events, attachments, comments and more. Investigators have access to see the protocols they’re investigating as well as attachments, events and documents generated for their study.

https://cchhs.my.irbmanager.com/Login.aspx
User Manual
Quick Sheet

Please email CCHHSIRB@cookcountyhhs.org  at the Office of Research & Regulatory Affairs to obtain a login and password. If you need assistance or would like to schedule a training session, please send an email to the address above.

Templates & Forms

Templates

Short Forms

Forms

HRPP Toolkit

SOPs

Worksheets

HRP-317-Worksheet-Shortform of Consent Documentation

Checklist

Training for Human Participant Research

All persons who are to be substantively involved in human participant research at Cook County Health must be properly trained.

Research & Regulatory Affairs is excited to introduce the CITI Program for Research Ethics and Compliance Training to Cook County Health. In order to ensure the protection of our research participants, our Human Subjects Research (HSR) / IRB training will now expire every 3 years. With over 800 active users in IRBManager, online certification is necessary to keep up with best practices and law changes, standardize the educational platform across institutions for multisite studies, and ensure our researchers meet single IRB and sponsor requirements.

Researchers looking to become certified for the first time will now complete the HSR CITI modules prior to their in-person training. You must have a Cook County Health ID to attend the in-person session. Researchers who have already completed the in-person training will only have to complete the CITI modules. Researchers who have not taken the in-person training in the last 3 years are required to complete the HSR course by the end of 2019. Those that have completed the in-person training within the last 3 years will be required to renew at their 3-year expiration date.

Cook County Health Guidelines for Investigators – Under Revision
CITI Program Instructions
CITI Program: https://www.citiprogram.org/login

Audits of Human Participant Research

The Office of Research & Regulatory Affairs conducts audits on research projects involving human participants.

Two types of audits are conducted: random post-approval monitoring audits and for-cause audits, which are a tool to provide insight to research related conduct at Cook County Health and achieve compliance with applicable federal regulations and laws as well as Cook County Health policies and procedures. Audits are also a vehicle for quality improvement, awareness of operations and continuing education.

The purpose of the audit is to review and inspect the ethical conduct of human participant research, adherence to the study protocol, and adherence to what is presented to the IRB as well as to participants in the informed consent process. Audits typically involve the review and inspection of informed consent forms, HIPAA authorization forms, IRB records, training documentation and data management/documentation with an emphasis on confidentiality and privacy procedures. Please click on the link below to access a checklist to help you prepare for your audit.

Cook County Health Audit Checklist

Fee Schedule

The Office of Research & Regulatory Affairs charges a processing/administrative fee for the Cook County Health IRB review of all industry sponsored human participant research.

IRB review fees are not charged for non-profit sponsored studies supported by the National Institutes of Health (NIH), other government agencies, foundations, or investigator-initiated studies. A one–time fee will be charged for the review of any new industry funded studies. There will be no charge for renewals, amendments/modifications, protocol deviations, unanticipated events involving risk, or final reports. Please click on the link below to access the current fee structure. These fees are subject to review and change.

Cook County Health Fee Structure Memo

Program Contact

Office of Research & Regulatory Affairs
Email